RA Effect on Cell Surface Molecules in Vivo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells

Condition or disease

Intervention/treatment

Phase

HIV Infections

Drug: Acitretin

Phase 1

Detailed Description:

Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.

Acitretin will be provided to participants in the formulation Soriatane. Soriatane doses are oral tablets taken daily by the participant. Participants will then receive 35mg of oral acitretin (Soriatane) daily for 8 weeks during the intervention phase. Participants will be asked to return two months after completion of the acitretin course for clinical follow-up and additional phlebotomy for laboratory testing.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:

18 Years to 65 Years (Adult, Older Adult)

Sexes Eligible for Study:

Male

Gender Based Eligibility:

Yes

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Male gender

Age 18 - 65

Able to provide informed consent

Willingness to participate in study treatment and follow-up

Willingness for serial phlebotomy and storage and future viro-immunological assays

Exclusion Criteria:

Female gender

Participants with a known hypersensitivity/allergy to the acitretin.

Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.

Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis